The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain

Mayo Clinic15 enrolled

Overview

The purpose of this research is to determine if mind and body counseling and training improves quality of life in women undergoing treatment for chronic pelvic pain.

Patients with chronic illnesses are expected to self-manage much of their treatment. Barriers include limited time during appointments, consultations with multiple different providers, technical communication style, health literacy issues, and a sense of feeling overwhelmed. Patients with chronic pain syndromes experience symptoms which can negatively impact their quality of life by interfering with ability to sleep, work, and function in their social roles. One proposed mechanism in chronic pain management is mindfulness. Mindfulness is the intentional and non-judgmental conscious awareness of the present moment, or "paying attention on purpose" with the goal of physical and psychological health improvement. Participants are taught autonomy, increasing self-regulation, and focusing awareness on a particular goal or activity. The investigators hypothesize that a mind-body counselor will improve patient engagement and promote adherence to pain coping treatments. If the initial findings from this project support the use of Integrative Medicine services in women with chronic pelvic pain, the investigators hope to expand this study to a larger, randomized controlled trial that is adequately powered to determine significant difference among participants in the control and study groups.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chronic Female Pelvic Pain Syndrome (Disorder)

Interventions

Mindfulness counselingBEHAVIORAL

Subjects three 60-minute mindfulness counseling sessions with a certified Mind-Body Counselor who has a degree in Social Work in the department of Integrative Medicine. The mindfulness sessions will be conducted entirely via telemedicine. The initial consultation will consist of a 60-minute individual session. The next session will be a group visit (plan for 5 subjects per group) lasting 60 minutes, which will be scheduled for 2 weeks after the initial session. The third session will be another 60-minute group session, which will be scheduled for 6 weeks after the initial session.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of chronic pelvic pain. * Must speak English. * Must be ages 18 through 89. * Must be willing and able to provide informed consent for participation. * Must have access to the Patient Online Services portal to complete the questionnaires. Exclusion Criteria: \- Diagnoses of primarily non-gynecologic pain, acute pelvic pain, and active abdominal or pelvic malignancy.

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Number of participants with improved quality of life scores on PROMIS-CAT questionnaires after treatment of chronic pelvic pain and enrollment in a mind-body training program

This outcome measure will demonstrate whether the proposed intervention showed improvement in symptomatology of subjects with chronic pain.

Time frame: 6 months

Secondary Outcomes

Number of participants who were able to attend all mind-body training sessions

This outcome measure will be used to determine adherence and attendance to the Integrative Medicine services.

Time frame: 6 months

Time from enrollment in the study until completion of all mind-body sessions

This outcome measure will determine feasibility of scheduling patients with Integrative Medicine services and determine waiting list times for this service.

Time frame: 6 months

Data from ClinicalTrials.gov

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